Breast CancerPhase 2NCT04192331
Nab-paclitaxel Dose Schedual for HER-2 Negative Advanced Breast Cancer
A Phase 2 study testing nab-paclitaxel regimen1 and nab-paclitaxel regimen2 in people with Breast Cancer, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial summary
What is the best dosage of Nab-Paclitaxel for chinese? This study would divide patients into two dosage groups: 1) 125mg/m2, 30 minutes intravenous injection, d1, 8, 21 days for a cycle(clinical use); 2) 125mg/m2 d1, 8, 15, 30 minutes intravenous injection, 28 days for a cycle(guideline recommand). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- nab-paclitaxel regimen1 and nab-paclitaxel regimen2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteChina
- Study dates
- 21 Feb 2019to 26 Jan 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female, aged≥ 18 years old;
- Histopathologically confirmed HER-2 negative (definition: immunohistochemical IHC 0, or 1+, or in situ hybridization ISH, defined as the ratio of HER2 gene copy number to CEP17 signal number less than 2.0, or for single probe detection, HER2 gene copy number less than 6) in patients with recurrent or metastatic breast cancer;
- Up to two previous lines of chemotherapy were permitted for recurrent and metastatic diseases. And for endocrine therapy, the number of treatment lines can be omitted;
- With measurable lesions;
- The physical condition score of the Eastern American Cancer Collaboration Group (ECOG) was less than 1;
- Expected survival period>3 months;
Who cannot join
- New York Heart Association NYHA scores identify patients with congestive heart failure at grade II or above;Uncontrolled brain metastasis;
- Patients with severe systemic infection;Patients with peripheral nerve injury of degree II or above, or known drug allergy or intolerance within 4 weeks before admission;
- Important organ disorders or diseases: liver and kidney dysfunction, history of myocardial infarction, unstable heart disease, chronic active hepatitis,etc;There is a history of other malignant tumors within 5 years (except cured cervical cancer or skin basal cell carcinoma);
- Patients who had received other antineoplastic treatments or other experimental drugs within one month before treatment;
- Patients who also participated in other clinical trials;
- Researchers believe that patients are not suitable for any medical condition to enter the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-arm Opened Randomized Phase II Study of Nab-paclitaxel Dose Schedual in Advanced Breast Cancer
What is the best dosage of Nab-Paclitaxel for chinese? This study would divide patients into two dosage groups: 1) 125mg/m2, 30 minutes intravenous injection, d1, 8, 21 days for a cycle(clinical use); 2) 125mg/m2 d1, 8, 15, 30 minutes intravenous injection, 28 days for a cycle(guideline recommand). Treatment to disease progression. The efficacy (CR, PR, SD, PD) is evaluated every 2-4 cycles.If the patient withdraws from the trial because he cannot tolerate the toxicity caused by one of the drugs, such as neurotoxicity or bone marrow toxicity, it is recommended to switch to other drugs and follow up to PFS and OS.Each group was planned to include 30 patients.
- Conditions
- Breast Cancer
- Being tested
- nab-paclitaxel regimen1, nab-paclitaxel regimen2
- Keywords
- nab-paclitaxel, advanced breast cancer, HER2 negative, dose
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nab-paclitaxel regimen1Drug
Also called regimen1
nab-paclitaxel regimen1 means use abraxine with 125mg/m2 at day 1 and day 8 per 21d.
nab-paclitaxel regimen2Drug
Also called regimen2
nab-paclitaxel regimen2 means use abraxine with 125mg/m2 at day 1 and day 8 and day 15 per 28d.
| Study group | Role | What they receive |
|---|---|---|
| 2/3dose strategy | Experimental | HER2 negative advanced breast cancer patient Receives: Drug: nab-paclitaxel regimen1 |
| 3/4dose strategy | Active comparator | HER2 negative advanced breast cancer patient Receives: Drug: nab-paclitaxel regimen2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS of two regimen
progession free survival and objective remission rate was put in to assessment after 2-4 cycle of treatment of either two regimen
Measured: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Secondary outcomes (1)
Side effect of two regimen
toxicity and tolerability would be evaluated after every cycle of treatment and will report a SAE within 24h
Measured: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start21 Feb 2019
- Primary completion26 Jan 2023 (estimated)
- Study completion26 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 97 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Huiping, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04192331
- Sponsor's protocol ID
- CABC012
- Status last verified
- Oct 2022
- First submitted
- 14 Apr 2019
- Last updated
- 13 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Liu Y, Song G, Di L, Jiang H, Ran R, Zhang R, Zhang Y, Li H. Three-Week Versus 4-Week Schedule of nab-Paclitaxel in Patients With Metastatic Breast Cancer: A Randomized Phase II Study. Oncologist. 2023 Dec 11;28(12):1102-e1302. doi: 10.1093/oncolo/oyad288.
PubMed 37882706
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm Opened Randomized Phase II Study of Nab-paclitaxel Dose Schedual in Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT04192331
- Acronym / sponsor ID
- CABC012
- Conditions
- Breast Cancer
- Keywords
- nab-paclitaxel, advanced breast cancer, HER2 negative, dose
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 97 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 21 Feb 2019 (actual)
- Primary completion
- 26 Jan 2023 (estimated)
- Study completion
- 26 Jan 2023 (estimated)
- First posted
- 10 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
What is the best dosage of Nab-Paclitaxel for chinese? This study would divide patients into two dosage groups: 1) 125mg/m2, 30 minutes intravenous injection, d1, 8, 21 days for a cycle(clinical use); 2) 125mg/m2 d1, 8, 15, 30 minutes intravenous injection, 28 days for a cycle(guideline recommand). Treatment to disease progression. The efficacy (CR, PR, SD, PD) is evaluated every 2-4 cycles.If the patient withdraws from the trial because he cannot tolerate the toxicity caused by one of the drugs, such as neurotoxicity or bone marrow toxicity, it is recommended to switch to other drugs and follow up to PFS and OS.Each group was planned to include 30 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2/3dose strategy | Experimental | Drug: nab-paclitaxel regimen1HER2 negative advanced breast cancer patient |
| 3/4dose strategy | Active comparator | Drug: nab-paclitaxel regimen2HER2 negative advanced breast cancer patient |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female, aged≥ 18 years old;
- Histopathologically confirmed HER-2 negative (definition: immunohistochemical IHC 0, or 1+, or in situ hybridization ISH, defined as the ratio of HER2 gene copy number to CEP17 signal number less than 2.0, or for single probe detection, HER2 gene copy number less than 6) in patients with recurrent or metastatic breast cancer;
- Up to two previous lines of chemotherapy were permitted for recurrent and metastatic diseases. And for endocrine therapy, the number of treatment lines can be omitted;
- With measurable lesions;
- The physical condition score of the Eastern American Cancer Collaboration Group (ECOG) was less than 1;
Key exclusion criteria (6 listed)
- New York Heart Association NYHA scores identify patients with congestive heart failure at grade II or above;Uncontrolled brain metastasis;
- Patients with severe systemic infection;Patients with peripheral nerve injury of degree II or above, or known drug allergy or intolerance within 4 weeks before admission;
- Important organ disorders or diseases: liver and kidney dysfunction, history of myocardial infarction, unstable heart disease, chronic active hepatitis,etc;There is a history of other malignant tumors within 5 years (except cured cervical cancer or skin basal cell carcinoma);
- Patients who had received other antineoplastic treatments or other experimental drugs within one month before treatment;
- Patients who also participated in other clinical trials;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nab-paclitaxel regimen1Also: regimen1nab-paclitaxel regimen1 means use abraxine with 125mg/m2 at day 1 and day 8 per 21d. | Drug | 2/3dose strategy |
| nab-paclitaxel regimen2Also: regimen2nab-paclitaxel regimen2 means use abraxine with 125mg/m2 at day 1 and day 8 and day 15 per 28d. | Drug | 3/4dose strategy |
Primary outcome
PFS of two regimen
Time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
progession free survival and objective remission rate was put in to assessment after 2-4 cycle of treatment of either two regimen
1 secondary outcome
Side effect of two regimen
Time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
- Derived from this study: PubMed 37882706Liu Y, Song G, Di L, Jiang H, Ran R, Zhang R, Zhang Y, Li H. Three-Week Versus 4-Week Schedule of nab-Paclitaxel in Patients With Metastatic Breast Cancer: A Randomized Phase II Study. Oncologist. 2023 Dec 11;28(12):1102-e1302. doi: 10.1093/oncolo/oyad288.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing nab-paclitaxel regimen1 and nab-paclitaxel regimen2 in people with Breast Cancer, run by Peking University Cancer Hospital & Institute at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS of two regimen (time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04192331, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2022.